Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients

NCT ID: NCT06900088

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-25
• Study Completion Date: 2026-10-30

Brief Summary

Efficacy and Safety of Selinexor Combined with Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Exploratory Study

Detailed Description

Treatment period: From the time of transplantation, after screening by inclusion and exclusion criteria, patients who meet the criteria are enrolled and given maintenance therapy with Selinexor in combination with azacitidine (Selinexor: 40 mg/weekly, administered on D1; azacitidine: 50 mg/m2*5d; every 28 days for a cycle of treatment, for at least one year of medication, or until progression of the disease, or until the development of intolerable toxicity, whichever comes first)

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients with high-risk myeloid neoplasms after transplantation

maintenance therapy with Selinexor combined with Azacitidine

Group Type: EXPERIMENTAL

Selinexor

Intervention Type: DRUG

maintenance therapy with Selinexor combined with Azacitidine in patients with high-risk myeloid neoplasms after transplantation

Interventions

Selinexor

maintenance therapy with Selinexor combined with Azacitidine in patients with high-risk myeloid neoplasms after transplantation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:

1. Age≥ 16 years old; any gender;

2. High-risk MDS (IPSS-R or/and IPSS-M high-risk and above);

3. High relapse risk AML, including relapsed refractory AML and patients with pre-transplant MRD-positive AML, i.e., patients who meet one of the following criteria:

(1)Refractory AML is defined as meeting one of the following conditions

1. Primary cases that have failed to respond to 2 courses of standard regimen chemotherapy;

2. CR was followed by consolidation and intensive treatment with no recurrence within 12 months;

3. It recurred 12 months later, but conventional chemotherapy was ineffective;

4. 2 or more relapses;

5. Extramedullary leukemia persists. (2)Relapsed AML i.e., re-initialization of leukemic cells in the peripheral blood after complete remission (CR) or bone marrow primitive cells >0.050 (except for other reasons such as bone marrow reconstitution after consolidation chemotherapy) or extramedullary infiltration of leukemic cells.

(3)Positive pre-transplant MRD, i.e., one of the following conditions is met:

1. Proportion of abnormal myeloid cells >0.01% by pre-transplant flow assay;

2. Positive pre-transplantation molecular biology-related tests. (4)AML with poor prognosis (according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Myeloid Leukemia (Non-Acute Promyelocytic Leukemia) 2023 Edition) 4.Meets WHO diagnostic criteria for staging CMML; 5.MDS or CMML transforms AML.

Exclusion Criteria

Patients with any of the following are not eligible for enrollment in this study:

1. Patients who relapsed within 3 months of transplantation or during maintenance therapy, including hematologic, molecular genetic, cytogenetic relapses, and extramedullary relapses.

2. Known positive serology for HIV or active hepatitis B virus (HBV) and hepatitis C virus (HCV);

3. Requirements for mental illness or other conditions that preclude cooperation with study treatment and monitoring;

4. Patients who are pregnant or who are unable to use appropriate contraception during treatment;

5. Suspected hypersensitivity to the experimental drug or any of its excipients;

6. Active heart disease, defined as one or more of the following:

（1）History of uncontrolled or symptomatic angina; （2）Myocardial infarction less than 6 months from study entry; （3）History of tardive dyskinesia requiring medication or clinically significant symptoms; （4）Uncontrolled or symptomatic congestive heart failure (> NYHA class 2) （5）Ejection fraction is below the lower limit of the normal range. 7. Those deemed unsuitable for enrollment by the investigator.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.

Tianjin, , China

Countries

China

Central Contacts

Erlie jiang

Role: CONTACT

jiangerlie@ihcams.ac.cn

+86-15122538106

Other Identifiers

IIT2024099

Identifier Type: -

Identifier Source: org_study_id